Prashanth Kamath Email & Phone Number

Pune, Maharashtra, India

Mysore, Karnataka, India

Coordinate workflow to ensure delivery of project. Distributing and monitoring team workload. Manual recoding of un-recoded products and substance terms from ICSRs. Identification and management of duplicate ICSRs. Activities related to Literature search review. Quality review for the work performed by peers. Served as a subject matter expert which includes resolution of project related routine queries, mentoring, and coaching. Managed a small team within the project. Distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety submissions team if contracted to submit the reports. Participated in audits/inspections as required. Ensured all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. Maintained understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process..

Thane, Maharashtra, India

Workflow Monitoring activities which include - Retrieving daily workflow reports and ensuring users are completing cases nearing the 7/15-day timelines.Monitoring compliance by identifying and prioritizing expedited cases up to completion.Review impacted cases daily and escalate/re-route cases to ensure follow up processing is initiated and completed in a timely manner.Monitor and maintain record of data correction requests including impact and actions taken.End to end case processing for different case types which includes ICSR, legal, Clinical trials, E2B.Training the team as and when required conducting knowledge assessments

Mumbai Area, India

Full data entry of all relevant information from the source dataManual coding of all codeable terms (that did not auto-encode), including adverse events, medical history, concomitant medications, and laboratory values.Writing narratives for ICSRs based on GLPS’s auto-narrative templates and conventions.